DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-7, 8-20 are pending in the application. Claims 18-20 are withdrawn. Claims 1-7, 8-17 are currently under examination.
This office action is in response to the amendment filed on 10/28/2025.
All previous rejection not reiterated in this office action are withdrawn.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 13 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by the sequence having accession number A0A1U7IPF8, A0A5E3ZX89, A0A418XZZ3, A0A0Q8SV90 or A0A1G5ZMQ4.
Claim 13 is directed to a nucleic acid sequence encoding the peptide of claim 1, but does not include conjugates because the conjugation is between the peptide and a second molecule, etc.
Regarding claim 13, since the amino acid sequence of the protein is known in prior art, nucleic acid encoding said amino acid sequence may be deduced from said amino acid sequence(s), A0A1U7IPF8, A0A5E3ZX89, A0A418XZZ3, A0A0Q8SV90 and A0A1G5ZMQ4.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 9, 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over the sequence having accession number A0A1U7IPF8, A0A5E3ZX89, A0A418XZZ3, A0A0Q8SV90 or A0A1G5ZMQ4.
Claim 1 is drawn to an adeno-associated virus (AAV) acoustic targeting peptide comprising an amino acid sequences that comprises amino acids selected from SEQ ID NO: 1-5, and conjugated to a nanoparticle, a second molecule, a viral capsid protein or a combination thereof.
A0A1U7IPF8 is a SPOR domain-containing protein that comprises 100% homology with SEQ ID NO:1 (see alignment).
A0A5E3ZX89 is a CsbD family protein that comprises a sequence having 100% homology with SEQ ID NO:2 (see alignment).
A0A418XZZ3 is pre-16S rRNA nuclease that comprises a sequence having 100% homology with SEQ ID NO:3 (see alignment).
A0A0Q8SV90 is bleomycin resistant protein that comprises a sequence having 100% homology with SEQ ID NO:4 (see alignment).
A0A1G5ZMQ4 is DUF982 domain containing protein that comprises a sequence having 100% homology with SEQ ID NO:5 (see alignment).
However, the prior art sequences do not specially indicated whether it is conjugated to a second molecule.
The specification does not give a limiting definition for the structural and/or function of the “second molecule.” As such, it is interpreted as any molecule that may be conjugated to a peptide. Although the protein comprises sequence with 100% homology with SEQ ID NO: 1, 2, 3, 4 or 5 are not disclosed as conjugated to a second molecule, it would have been obvious to an ordinary skilled in the art to recognize they may be conjugated to different kinds of “second molecule” such as tags, beads and/or solid particle for purification and/or detection purpose. Therefore, the claimed invention of claims 1-7 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claim 9 and 10, the “wherein” clause (configuration or demonstration) does not further limit the claim to a particular structure. As such, the prior art sequence anticipates these claim.
Response to Arguments
Applicant argues that there would be no reason to conjugate a protein of cited art, e.g. a bacterial CsbD family protein to “a nanoparticle, a second molecule, a viral capsid protein, or a combination thereof” as claimed.
This argument has been fully considered but deemed unpersuasive. As discussed in the above rejection, the bacterial protein may be conjugated to purification tag etc, for protein purification purpose. Since the specification does not give a description what “second molecule” is limited to, any peptide tag and/or beads used commonly in the prior art for protein purification would meet this claim limitation.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 9-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is rewritten to address the amendment.
The written description requirement is set forth by 35 U.S.C. 112, first paragraph which states that the: “specification shall contain a written description of the invention. . .[emphasis added].” The written description requirement has been well established and characterized in the case law. A specification must convey to one of skill in the art that “as of the filing date sought, [the inventor] was in possession of the invention.” See Vas Cath v. Mahurkar 935 F.2d 1555, 1560 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). Applicant may show that he is in “possession” of the invention claimed by describing the invention with all of its claimed limitations “by such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention.” See Lockwood v. American Airlines Inc. 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997).
In analyzing whether the written description requirement is met, it is first determined whether a representative number of species have been described by their complete structure. Next, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics. Claim 1 recites an AAV acoustic targeting peptide comprising an amino acid sequence that comprises amino acids from SEQ ID NO: 1-5, conjugated to a nanoparticle and large genus of “second molecule” of unknown nature. The term “acoustic targeting peptide” is interpreted as targeting AAV to specific location across blood-brain-barrier (BBB) with focused ultrasound (FUS-BBBO). The claimed genus of peptide potentially encompasses a large number of peptide that comprises the amino acid from SEQ ID NO: 1-5. However, the specification only describes 5 peptides that consists of all amino acids of SEQ ID NO: 1-5 (7 randomized amino acids), when inserted into AAV capsid of AAV9 at 588 and 589, demonstrated increased transduction (example 1). The specification also teaches 7-mer insertions have been widely used to engineer AAVs with new properties (page 99, paragraph [0319]). The specification however fails to describe any other peptides that comprises the amino acids from SEQ ID NO: 1-5, that still have the “acoustic targeting” function for AAV. Claim 10 further recites said peptide have the function of at least about 1.1 fold increase in transduction at sites of FUS-BBBO, neuronal tropism and/or 1.1 fold decrease in transduction in peripheral organs as compared to wild type AAV without said peptide. There is no description of what nanoparticle conjugation, and/or other “second molecule” conjugation would retain said function as recited. Therefore, the specification fails to describe a representative number of species of the claimed genus of peptide by their complete structure, or other identifying characteristics.
The knowledge in prior art does not remedy this deficiency. As demonstrated in the above art rejection, there are many different types of protein (sequence such as A0A1U7IPF8) comprises the 7-mer sequence set forth in SEQ ID NO: 1-5. Each protein has different function than the “acoustic targeting” of AAV. As such, whether such protein/peptide that has the amino acids from SEQ ID NO: 1-5 conjugates with other unknown molecule has acoustic targeting function is unpredictable. A skilled artisan cannot immediately envision the structural property of the claimed genus of peptides based on the function of “acoustic targeting” of AAV because the structural and functional relationship is missing. Therefore, the present as filed specification fails to describe the claimed invention in such a way to convey a skilled artisan that the inventors had possession of the invention at the time the application was filed.
Response to Arguments
Applicant states that the amendment presented in the response filed on 10/28/2025 overcomes this rejection.
This argument is not persuasive for reason discussed in the above rewritten rejection.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637
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